OSLO, NORWAY--(Marketwired - Aug 28, 2013) -
Intended for US media only
Algeta ASA (OSE: ALGETA), a company focused on
the development of novel targeted cancer therapeutics, announces its
the first half and second quarter 2013.
A presentation of the results in Oslo will be webcast live from 10:00
can be accessed through www.algeta.com. An international conference call
take place at 14:30 CET/ 08:30 EST (US). Details of both events are at
of this announcement.
"We were delighted that Xofigo(®) (radium Ra 223 dichloride)
approved and launched in the US in May. These major milestones
significant effort and commitment of everyone involved in the drug's
over the past decade and more," said Andrew Kay, Algeta President & CEO.
Bayer, we are now executing our launch strategy in the US and are pleased
the progress being made."
Oystein Soug, Algeta's Chief Financial Officer, added, "Algeta has
EUR 100m in milestone payments from Bayer during 2013 which will enable
fully invest in the US launch of Xofigo alongside Bayer. In addition
financial profile, our proven development expertise in oncology and our
commercial experience and infrastructure provide us with the confidence to
to build a broad portfolio of novel cancer therapeutics beyond Xofigo."
In September 2009, Algeta signed an agreement with Bayer for the
commercialization of Xofigo. Under the terms of the agreement, Bayer
develop, apply for health authority approvals worldwide and commercialize
globally. Algeta is eligible for royalties and milestones based on Bayer's
of Xofigo outside the US, and Algeta US, LLC is co-promoting Xofigo with
in the US.
Highlights of the second quarter 2013:
Xofigo (radium Ra 223 dichloride) injection
* On 15 May 2013, the US Food and Drug Administration (FDA) approved
(radium Ra 223 dichloride) injection for the treatment of patients
castration-resistant prostate cancer (CRPC), symptomatic bone metastases
no known visceral metastatic disease.
* On 30 May, Algeta announced that Xofigo had been launched in the US and
first sale had been made, triggering a EUR 50m milestone payment to
from Bayer. Algeta US, LLC and Bayer Healthcare are co-promoting Xofigo
* The launch of Xofigo is being executed by Algeta and Bayer to an
plan, and both companies are working in their respective territories
ensure that physicians are aware of Xofigo and its approved label. A
part of the launch activities is to provide information and support
administering centers to get licensed to procure and administer Xofigo.
* In June, Algeta celebrated the official opening of its commercial
facility for Xofigo, located at the Institute for Energy Technology (IFE)
Norway. All material for commercial sale and for clinical trials world-
is currently produced in this facility.
Targeted Thorium Conjugates (TTCs)
* In May, and to facilitate the conjugation of thorium-227 to
molecules in its TTC research, Algeta announced the exercise of its
to take an exclusive worldwide license to patented Lumi4(®) bi-
chelator technology from Lumiphore, Inc. and an extension of
collaboration to include additional chelator families.
* In June, Algeta announced a collaboration with Avipep Pty Ltd to
novel TTC that combines Algeta's thorium-227 payload with an
from Avipep that targets a number of different solid tumor types.
* Data from the phase III ALSYMPCA trial were published in the 18 July 2013
issue of the New England Journal of Medicine.
* In August, Dr Andreas Menrad was appointed Chief Scientific
bringing more than 20 years of experience in oncology and
antibody development. He was formerly CSO at Ablynx NV, and
previously at Genzyme (Sanofi) as General Manager and Vice President
* Operating revenue for the second quarter 2013 amounted to NOK 444m
with NOK 55m in the same period in 2012. Revenues were NOK 515m in the
half of 2013 vs NOK 128m in same period in 2012.
* In the second quarter 2013, net sales of Xofigo in the US market
by Bayer) amounted to NOK 3m (USD 0.6m) compared to nil in the same
* Algeta's recognized share of the net result of US co-promotion
for the second quarter 2013 was an expense of NOK 70m, compared with
expense of NOK 27m in the same period in 2012. Algeta recognizes 50% of
net result of Xofigo co-promotion activities in the US.
* Core operating expenses, which exclude currency effects, interest
and costs directly related to the commercial launch in the US, for the
second quarter 2013 amounted to NOK 120m, compared with NOK 80m in the same
period in 2012.
* Net cash amounted to NOK 565m as at 30 June 2013 compared with NOK 369m
of the 31 December 2012.
The First Half and Second Quarter Report 2013 and accompanying presentation
be available through www.algeta.com from 07:00 CET today.
Details of presentation and webcast
A presentation by Algeta's executive management team to investors,
the press will take place in Oslo at 10:00 CET.
Haakon VIIs gate 9
The presentation will also be webcast live and can be accessed
www.algeta.com. Questions can be submitted live during the webcast.
Details of international conference call
An international conference call will take place at 14:30 CET/ 08:30 EST
To participate in the conference call, please dial the appropriate number
five minutes prior to the call:
US: +1 877 423 0830
UK: +44 20 7153 9154
Norway: +47 21 06 61 13
Sweden: +46 8-506 443 86
Denmark: +45 32 71 42 62
Switzerland: +41 44 580 65 22
Participant pin code: 197187#
To access the replay, please dial:
US: +1 877 679 2989
UK: +44 20 3364 5200
Norway: +47 23 50 02 03
Sweden: +46 8-505 564 73
Conference reference: 348084#
A replay of the conference call will also be available at www.algeta.com.
About radium Ra 223 dichloride
Radium Ra 223 dichloride (radium 223) is currently not approved by the
Medicines Agency (EMA) or other authorities outside the US. Bayer
Marketing Authorisation Application to the EMA for radium 223 in December
and subsequently in other territories.
Radium 223 (as Xofigo(®) injection) is approved in the United
States and is
indicated for the treatment of patients with castration-resistant
cancer (CRPC), symptomatic bone metastases and no known visceral
Radium 223 is an alpha particle-emitting radioactive therapeutic agent with
anti-tumor effect on bone metastases. The active ingredient in radium 223
alpha particle-emitting isotope radium-223, which mimics calcium and forms
complexes with the bone mineral hydroxyapatite at areas of increased bone
turnover, such as bone metastases. The high linear energy transfer of
223 may cause double-strand DNA breaks in adjacent cells, resulting in an
tumor effect on bone metastases. The alpha particle range from radium-223
less than 100 micrometers which may limit the damage to the surrounding
Important Safety Information for Xofigo (radium Ra 223 dichloride) in the
Xofigo is contraindicated in women who are or may become pregnant.
cause fetal harm when administered to a pregnant woman.
In the randomized trial, 2% of patients in the Xofigo arm experienced
marrow failure or ongoing pancytopenia, compared to no patients treated
placebo. There were two deaths due to bone marrow failure. For 7 of 13
treated with Xofigo bone marrow failure was ongoing at the time of death.
the 13 patients who experienced bone marrow failure, 54% required
transfusions. Four percent (4%) of patients in the Xofigo arm and 2%
placebo arm permanently discontinued therapy due to bone marrow
the randomized trial, deaths related to vascular hemorrhage in association
myelosuppression were observed in 1% of Xofigo-treated patients
0.3% of patients treated with placebo. The incidence of infection-related
(2%), serious infections (10%), and febrile neutropenia (less than
similar for patients treated with Xofigo and placebo. Myelosuppression -
thrombocytopenia, neutropenia, pancytopenia, and leukopenia - has been
in patients treated with Xofigo.
Monitor patients with evidence of compromised bone marrow reserve
provide supportive care measures when clinically indicated. Discontinue
in patients who experience life-threatening complications despite
care for bone marrow failure.
Monitor blood counts at baseline and prior to every dose of Xofigo.
first administering Xofigo, the absolute neutrophil count (ANC)
greater than to equal to 1.5 × 10(9)/L, the platelet count greater
than or equal
to 100 × 10(9)/L, and hemoglobin greater than or equal to 10
g/dL. Prior to
subsequent administrations, the ANC should be greater than or equal
to 1 ×
10(9)/L and the platelet count greater than or equal to 50 ×
Discontinue Xofigo if hematologic values do not recover within 6 to 8
after the last administration despite receiving supportive care.
Safety and efficacy of concomitant chemotherapy with Xofigo have not
established. Outside of a clinical trial, concomitant use of Xofigo in
on chemotherapy is not recommended due to the potential for
myelosuppression. If chemotherapy, other systemic radioisotopes, or
external radiotherapy are administered during the treatment period,
should be discontinued.
Xofigo should be received, used, and administered only by authorized
designated clinical settings. The administration of Xofigo is associated
potential risks to other persons from radiation or contamination from
bodily fluids such as urine, feces, or vomit. Therefore, radiation
precautions must be taken in accordance with national and local
The most common adverse reactions (greater than or equal to 10%) in the
arm vs. the placebo arm, respectively, were nausea (36% vs 35%) diarrhea
15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3
adverse events were reported in 57% of Xofigo-treated patients and
placebo-treated patients. The most common hematologic laboratory
in the Xofigo arm (greater than or equal to 10%) vs the placebo
respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs.53%),
(35% vs. 10%), thrombocytopenia (31% vs. 22%), and neutropenia (18% vs.
For full US prescribing information visit www.xofigo-us.com.
Algeta is a company focused on developing, manufacturing and marketing
targeted therapies for patients with cancer. The Company is
Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in
performing commercial marketing operations in the US. Algeta is listed
Oslo Stock Exchange (Ticker: ALGETA). For more information please
This news release contains certain forward-looking statements that are
uncertainty, as they relate to events and depend on circumstances that
occur in the future and which, by their nature, may have an impact on
operations and the financial condition of Algeta. Such forward-
statements reflect our current views and are based on the information
available to Algeta. Algeta cannot give any assurance as to whether such
looking statements will prove to be correct. These forward looking
include statements regarding our co-promotion of Xofigo in the US
development of our other product candidates. There are a number of factors
could cause actual results and developments to differ materially from
expressed or implied by these forward-looking statements. These factors
among other things, general economic and business conditions, the
competition, the ability to successfully commercialize Xofigo, the risk
costs associated with the co-promotion of Xofigo may be greater
anticipated, the risk that research & business development will not
products that achieve commercial success, manufacturing capacity, the
non-approval of patents not yet granted, risks in obtaining regulatory
for radium 223 and our other products and difficulties of obtaining
governmental approvals for new products, and the other risks and
described in our annual report.
Xofigo® is a registered trademark of Bayer
Lumi4® is a registered mark of Lumiphore, Inc.
 Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer,
C. et al. New England Journal of Medicine 2013; 369 (3) 213-223.
 Defined as the sum of External R&D expenses, Payroll and related costs,
Depreciation (including change in inventory) and General and Administrative
expenses. Core operating expenses do not include costs from co-promotion
 XOFIGO Prescribing information. May 2013
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Source: Algeta ASA via Thomson Reuters ONE